503A vs. 503B – WHAT’S THE DIFFERENCE?

Written By High Five

The Food and Drug Administration (FDA) has two sectors for compounding pharmacies: 503A and 503B. What is a 503A? A 503A is a compounding pharmacy that compound in accordance to...

The Food and Drug Administration (FDA) has two sectors for compounding pharmacies: 503A and 503B.

What is a 503A?

A 503A is a compounding pharmacy that compound in accordance to individual patients. These compounding pharmacies are not allowed to compound or sell in large batches, only patient specific.

What is a 503B?

A 503B is an outsourcing facility that is able to manufacture large batches to be sold to healthcare facilities for office use. Since 503B facilities are made in larger batches they are able to lower their manufacturing costs, which passes the savings on to their clients.

Regulatory Standards

503B compounding pharmacies are held to higher regulatory standards than 503As. This requires all 503Bs to maintain full compliance with cGMP. This includes validating every process according to cGMP and producing multiple batches and submitting them for testing and stability before new products can be brought to the market.

All 503B products and testing methods must be validated according to USP. All suppliers and vendors providing raw materials must be vetted and on-site inspection must be performed by quality personnel.

As a quick breakdown:

503As:

  • Must Comply with USP <795> and <797> along with state board of pharmacy regulations

  • Environmental Monitoring must be performed every six months

  • Beyond Use Dating (BUD) may be assigned based on internal or external scientific literature showing stability

503Bs:

  • Must Comply with USP <795> and <797> along with state board of pharmacy regulations and 21 CFR Part 210 and 211 (CGMP)

  • An Environmental Monitoring program must be developed and performed, at minimum, per production shift in the ISO 5 primary compounding areas and weekly in the secondary compounding areas (ISO 7 and ISO 8)

  • Organizations must maintain their own quality department must as an independent entity of operations and sales with complete autonomy for investigations and releasing product

  • Organizations are required to register with each state board of pharmacy, DEA and FDA and report their product list to FDA biannually

For more information, visit https://www.fda.gov/drugs/human-drug-compounding/fdc-act-provisions-apply-human-drug-compounding

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